NITE - Chemical Management Field

Latest GHS Classification Results by the Japanese Government (edited by NITE)

GENERAL INFORMATION

Item	Information
CAS RN	95-69-2
Chemical Name	4-chloro-o-toluidine
Substance ID	m-nite-95-69-2_v1
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	To Guidance List
UN GHS document (External link)	To UN GHS document
FAQ（GHS classification results by the Japanese Government）	To FAQ
List of Information Sources (Excel file)	List of Information Sources
List of Definitions/Abbreviations	Definitions/Abbreviations
Sample Label by MHLW (External link)	To Workplace Safety Site (MHLW)
Sample SDS by MHLW (External link)	To Workplace Safety Site (MHLW)
OECD/eChemPortal (External link)	To OECD/eChemPortal (External link)

PHYSICAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Explosives	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecules.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
7	Flammable solids	Not classified	- -	-	-	Since the substance does not ignite readily (ERG, 2008), it is not readily combustible.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
8	Self-reactive substances and mixtures	Not classified (Not applicable)	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
10	Pyrophoric solids	Not classified	- -	-	-	Its autoignition point is > 540degC (Hommel (1996)), which is > 70degC.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to solid (melting point <= 140degC) substances are not available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified (Not applicable)	- -	-	-	The chemical structure of the substance does not contain metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Organic compounds containing chlorine (but not fluorine and oxygen), with chlorine chemically bonded only to carbon.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
17	Desensitized explosives	-	- -	-	-	-	-	-

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Acute toxicity (Oral)	Category 4	Warning	H302	P301+P312 P264 P270 P330 P501	Based on the rat LD50 of 1000mg/kg (DFGOT vol. 6 (1994)), the substance was classified into Category 4.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Dermal)	Category 4	Warning	H312	P302+P352 P362+P364 P280 P312 P321 P501	Based on the rat LD50 of 1800mg/kg (DFGOT vol. 6 (1994)), the substance was classified into Category 4.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
2	Skin corrosion/irritation	Classification not possible	- -	-	-	Occlusive application of the substance to the skin of rats for 24 hours did not cause local skin irritation (DFGOT vol. 6 (1994)). However, the tests were not conventional skin irritation tests with their focus on acute toxicity. As such, classification is not possible based only on this result.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
4	Skin sensitization	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
5	Germ cell mutagenicity	Category 2	Warning	H341	P308+P313 P201 P202 P280 P405 P501	While negative results were obtained from in vivo reciprocal translocation tests using mice (in vivo heritable mutagenicity tests) and micronucleus tests using the bone marrow cells of Chinese hamsters (in vivo mutagenicity tests using somatic cells), positive results were obtained from mouse spot tests (in vivo mutagenicity tests using somatic cells) (DFGOT vol. 6 (1994)). Based on the positive results, the substance was classified into Category 2. Since there are no in vivo data on 4-chloro-o-toluidine, and all evaluations have been made on its hydrochloride compound, classification was done based on these evaluations. As relevant notes, DNA integration tests using livers of mice and rats (in vivo genotoxicity tests using somatic cells) yielded negative results, while in vitro mutagenicity tests using several indices (reverse mutation tests using bacteria, and chromosomal aberration tests using cultured mammalian cells, etc) yielded positive results.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
6	Carcinogenicity	Category 1B	Danger	H350	P308+P313 P201 P202 P280 P405 P501	Based on Group 2A classification by IARC (IARC 77 (2000)) and Group 2A classification by Japan Society for Occupational Health (Recommendations of Occupational Exposure Limits vol. 49 (2007)), the substance was classified into Category 1B. In the oral route exposure tests in which rats were exposed for 94-107 weeks and mice were exposed for 80-99 weeks, frequencies of liver cancer and overgrowth of glands increased in rats; and frequencies of angiosarcoma, reticulum sarcoma and other malignant tumors increased in mice, with all increases occurred in a dose-dependent fashion (IARC 77 (2000), DFGOT vol. 6 (1994), NTP 11th, report on carcinogens (1988)). In addition, there are several reports on the results of epidemiological surveys that indicate increased cases of bladder cancer in humans through occupational exposure (IARC 77 (2000), DFGOT vol. 6 (1994)).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
7	Reproductive toxicity	Classification not possible	- -	-	-	Insufficient data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
8	Specific target organ toxicity - Single exposure	Category 1 (urinary bladder, blood)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	The effects 4-chloro-o-toluidine exposure on industrial workers resulted in bloody urine, in some cases, accompanied with pain on urination and exfoliation of urinary bladder epithelium. Furthermore, cases of difficulty in urination, decreased capacity of the urinary bladder and lower abdominal pain were noted; and necrotic epithelial damage, bleeding, and edemas were detected in cystoscopy. In these cases, methemoglobinemia was observed in about a half of the affected workers. From these results, the substance was classified into Category 1 (urinary bladder, blood).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
9	Specific target organ toxicity - Repeated exposure	Category 1 (urinary bladder, blood system)	Danger	H372	P260 P264 P270 P314 P501	As the result of 4-chloro-o-toluidine exposure, bloody urine has been reported in many production plant workers (DFGOT vol. 6 (1994)). Documented cases of accidental inhalation or dermal exposure include bloody urine, difficulty in urination, frequent urination, occasional abdominal pain, cystitis, cystorrhagia, cyanosis, methemoglobinemia and decreased amount of hemoglobin (DFGOT vol. 6 (1994)). Acute hemorrhage cystitis was detected by bladder biopsy, which involved desquamation of urinary bladder epithelium and focal ulceration of mucous membranes (DFGOT vol. 6 (1994)). Based on the fact that bladder injuries resulted from exposure to this substance have been reported several times from epidemiological surveys, and based on cyanosis, methemoglobinemia, and decreased amount of hemoglobin documented, the substance was classified into Category 1 (urinary bladder, blood).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
11	Hazardous to the aquatic environment Short term (Acute)	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
11	Hazardous to the aquatic environment Long term (Chronic)	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
12	Hazardous to the ozone layer	-	- -	-	-	-	-	-

NOTE:

GHS Classification Result by the Japanese Government is intended to provide a reference for preparing a GHS label or SDS for users. To include the same classification result in a label or SDS for Japan is NOT mandatory.
Users can cite or copy this classification result when preparing a GHS label or SDS. Please be aware, however, that the responsibility for a label or SDS prepared by citing or copying this classification result lies with users.
This GHS classification was conducted based on the information sources and the guidance for classification and judgement which are described in the GHS Classification Guidance for the Japanese Government etc. Using other literature, test results etc. as evidence and including different content from this classification result in a label or SDS are allowed.
Hazard statement and precautionary statement will show by hovering the mouse cursor over a code in the column of "Hazard statement" and "Precautionary statement," respectively. In the excel file, both the codes and statements are provided.
A blank or "-" in the column of "Classification" denotes that a classification for the hazard class was not conducted in the year.
An asterisk “*” in the column of “Classification” denotes that “Not classified (or No applicable)” and/or “Classification not possible” is applicable. Details are described in the column of “Rationale for the classification”. If no English translation is available for “Rationale for the classification,” please refer to the Japanese version of the results.

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